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GYRE THERAPEUTICS, INC. (GYRE)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 revenue grew 20% YoY to $30.6M with operating income up 64% to $6.9M; GAAP net income rose to $5.9M and adjusted net income to $8.8M as ETUARY® rebounded and new launches contributed modestly .
  • Full-year 2025 revenue guidance was lowered to $115–$118M (from $118–$128M) due to delayed Etorel® rollout and government procurement uncertainty, partially offset by stronger ETUARY® sales; this guidance reset is the key stock narrative pivot near term .
  • Product mix shifted back toward the core franchise: ETUARY® sales increased to $27.7M (vs. $25.3M in Q3’24), while Etorel® and Contiva® contributed $1.5M and $1.2M, respectively .
  • Pipeline/regulatory: Hydronidone China NDA Priority Review discussions ongoing; U.S. IND for MASH shifted to 2026 to incorporate full China data and a hepatic impairment study—timing that may temper U.S. optionality near term but clarifies execution steps .
  • Liquidity strengthened: cash, cash equivalents, and deposits totaled $80.3M at 9/30/25 (vs. $75.9M at 6/30/25), providing flexibility through launch optimization and regulatory milestones .

What Went Well and What Went Wrong

What Went Well

  • ETUARY® regained momentum as marketing refocused; sales reached $27.7M in Q3, up from $23.5M in Q2 and $25.3M in Q3’24, supporting revenue and margin recovery .
  • Profitability inflected: operating income rose to $6.9M (+64% YoY) and GAAP net income to $5.9M; non‑GAAP adjusted net income of $8.8M reflected disciplined cost control and improved mix .
  • Positive strategic tone: “we are working diligently toward our NDA submission…leveraging Hydronidone’s Breakthrough Therapy designation” and advancing key trials (pirfenidone PD; planned RILI Phase 2/3) .

What Went Wrong

  • Guidance cut: FY25 revenue guidance reduced to $115–$118M (from $118–$128M) on slower‑than‑expected Etorel®/Contiva® commercialization and procurement-related caution among customers .
  • Launch friction: early supply chain/distribution delays and volume‑based procurement uncertainty weighed on Etorel® and Contiva® uptake vs. internal plans .
  • U.S. timing push: Hydronidone U.S. IND for MASH moved to 2026 to incorporate complete China data and hepatic impairment study learnings; delays can pressure U.S. optionality and timelines .

Financial Results

Headline P&L (oldest → newest)

MetricQ3 2024Q2 2025Q3 2025
Revenue ($USD Millions)$25.488 $26.771 $30.564
Cost of Revenues ($USD Millions)$0.958 $1.151 $1.628
Gross Profit ($USD Millions)$24.53 (calc from rev & CoR) $25.62 (calc) $28.94 (calc)
Income from Operations ($USD Millions)$4.233 $2.171 $6.925
Net Income ($USD Millions)$2.856 $1.576 $5.936
Basic EPS ($)$0.01 $0.00 $0.04
Diluted EPS ($)$0.01 $0.00 $0.03
Non‑GAAP Adjusted Net Income ($USD Millions)$4.395 $2.932 $8.799
Operating Margin (%)16.6% (calc) 8.1% (calc) 22.7% (calc)
Net Income Margin (%)11.2% (calc) 5.9% (calc) 19.4% (calc)

Note: Calculated metrics derived from cited figures.

Growth vs Prior Year and Prior Quarter

MetricYoY vs Q3 2024QoQ vs Q2 2025
Revenue+20.0% (calc) +14.2% (calc)
Income from Operations+63.6% (calc) +219% (calc)
Net Income+108% (calc) +277% (calc)
Non‑GAAP Adjusted Net Income+100% (calc) +200% (calc)

Product Sales Breakdown (oldest → newest)

Product Revenue ($USD Millions)Q1 2025Q2 2025Q3 2025
ETUARY® (pirfenidone)$21.7 $23.5 $27.7
Etorel® (nintedanib)Pre‑launch — on track for May’25 $1.6 $1.5
Contiva® (avatrombopag)$0.3 $1.5 $1.2
Total Revenue$22.058 $26.771 $30.564

KPIs and Operating Metrics (oldest → newest)

KPIQ1 2025Q2 2025Q3 2025
Cash, Cash Equivalents, and Deposits ($M)$51.3 $75.9 $80.3
Cash & Cash Equivalents ($M)$15.0 $36.5 $40.4
Short‑term Bank Deposits ($M)$14.8 $17.9 $19.6
Long‑term Certificates of Deposit ($M)$21.4 $21.5 $20.3
Selling & Marketing Expense ($M)$10.841 $15.194 $15.328
R&D Expense ($M)$3.095 $3.425 $2.363
G&A Expense ($M)$4.955 $4.829 $4.319
Cost of Revenues ($M)$0.894 $1.151 $1.628

Versus Estimates

  • Wall Street consensus for Q3 2025 EPS and revenue was unavailable via S&P Global at the time of retrieval; estimate comparisons cannot be provided at this time.*

*Values retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChangeNotes
Total Revenue ($M)FY 2025$118–$128 $115–$118 LoweredSlower Etorel®/Contiva® rollout; centralized procurement uncertainty; partly offset by stronger ETUARY®

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2 2025)Current Period (Q3 2025)Trend
Hydronidone (CHB) China NDAPivotal Ph3 positive; planned NMPA NDA in Q3’25 Priority Review discussions ongoing; proceeding to submission post regulatory interactions Advancing toward filing
Hydronidone (MASH) U.S.Phase 2 expected to start 2H’25 subject to feedback U.S. IND shifted to 2026 pending full China data translation and hepatic impairment study Timeline extended
ETUARY® (pirfenidone)Q1 softness expected; leadership maintained Marketing refocus drove Q3 growth; expected to continue into Q4 Re-acceleration
Etorel® (nintedanib)Launched June; $1.6M Q2 sales $1.5M Q3 sales; rollout impacted by supply/distribution delays and procurement caution Slower than plan
Contiva® (avatrombopag)Commercialization initiated Mar’25; $1.5M Q2 $1.2M Q3; procurement dynamics creating uncertainty Moderating
Procurement/MacroNotable in H1: weaker China conditions, competition in IPF Centralized procurement uncertainty driving cautious purchasing behavior Heightened headwind
R&D execution (pirfenidone PD, RILI)NMPA approval for RILI trial; PD Ph3 progressing PD Ph3 enrollment completed; RILI adaptive Ph2/3 initiation planned Q4’25 On track/advancing

Note: No Q3’25 earnings call transcript was available in our document set; themes reflect press releases and filed materials .

Management Commentary

  • “Following the positive results from our pivotal Phase 3 trial in the PRC evaluating Hydronidone for the treatment of CHB-associated liver fibrosis, we are working diligently toward our NDA submission and are leveraging Hydronidone’s Breakthrough Therapy designation to bring this much-needed therapy to patients in China.” — Ping Zhang, Executive Chairman and Interim CEO .
  • On U.S. timing: Hydronidone U.S. IND for MASH shifted to 2026 to integrate complete China Ph2/Ph3 data and conduct a hepatic impairment study, aligning dose selection and enrollment criteria with market dynamics .
  • Commercial focus: Marketing reallocated back to ETUARY® in Q3 as procurement uncertainty affected new launches, with ETUARY® expected to continue growth into Q4 .

Q&A Highlights

  • No Q3 2025 earnings call transcript was identified in company filings during this period; Q&A highlights are therefore unavailable based on primary source documents.

Estimates Context

  • S&P Global consensus estimates for Q3 2025 EPS and revenue were unavailable at time of retrieval; as a result, we cannot quantify beats/misses versus Street for this quarter.*
  • Given the guidance reset and launch dynamics, Street models may need to reduce FY25 revenue assumptions toward $115–$118M and temper near-term Etorel®/Contiva® ramps while increasing ETUARY® contribution, consistent with management commentary .

*Values retrieved from S&P Global.

Key Takeaways for Investors

  • Quality of beat vs internal drivers: Strong ETUARY® rebound plus disciplined OpEx produced significant operating leverage in Q3; mix shift back to the core franchise was the key driver .
  • Guidance reset de-risks 2H setup: Lowered FY revenue guide reflects realistic launch pacing and procurement headwinds; watch for Q4 ETUARY® follow‑through and any incremental color on procurement landscape .
  • Launchs’ trajectory is the swing factor: Etorel®/Contiva® underperformance vs plan was the main drag; improvements depend on supply chain normalization and procurement clarity .
  • China regulatory catalyst: Hydronidone China NDA submission under Priority Review discussions is a tangible near‑term asset catalyst; any clarity on timelines would be stock‑moving .
  • U.S. optionality pushed right: MASH U.S. IND to 2026 lowers near‑term optionality but may improve probability of success through better dose and population definition .
  • Balance sheet supports execution: $80.3M in cash and deposits provides runway to navigate launches and regulatory steps without immediate financing pressure .
  • Trading setup: Near term, focus on Q4 ETUARY® momentum versus procurement overhang and any incremental disclosure on China NDA progress; medium term, monitor launch conversion for Etorel®/Contiva® and U.S. program milestones .